Evaluation of the decrease of the secretion of saliva in patients with amyotrophic lateral sclerosis by a local ultrasound-guided bilateral injection of botulinum toxin type A in parotids and submandibular glands. The investigators want to demonstrate 1 month after the injection, by a multicenter French randomized double blind study, an improvement of at least 25 % of the functional embarrassment due to saliva, estimated with a visual analogue scale, a decrease of the quantity of saliva and a decrease of the embarrassment for the main caregiver.

Demonstrate after the injection of botulinum toxin type A an improvement of at least 25 % of the functional embarrassment provoked by sialorrhea in the ALS patient, evaluated with a horizontal visual analogue scale (VAS).

Secondary Outcome Measures:

Decrease of the salivary secretion rate and a decrease of the embarrassment for the main caregiver [ Time Frame: 1 month after the injection ] [ Designated as safety issue: No ]

Demonstrate, one month after the injection of botulinum toxin type A, a decrease of the salivary secretion rate and a decrease of the embarrassment for the main caregiver by a horizontal visual analogue scale.

Improvement of the value of the hypersalivation item in ALSFRS-R scale [ Time Frame: 1 month after the injection ] [ Designated as safety issue: No ]

Demonstrate, one month after the injection of botulinum toxin type A, an improvement of the value of the hypersalivation item in ALSFRS-R scale.

Decrease of the score of severity and frequency of the drooling rating scale [ Time Frame: 1 month after the injection ] [ Designated as safety issue: No ]

Demonstrate, one month after the injection of botulinum toxin type A, a decrease of the score of severity and frequency of the drooling rating scale

Decrease of the cotton roll weight [ Time Frame: 1 month after the injection ] [ Designated as safety issue: No ]

Demonstrate, one month after the injection of botulinum toxin type A, a decrease of the cotton roll weight.

Cotton rolls weight: production and quantity of saliva are verified by placing dental cotton rolls during 3 minutes in the mouth of the patient and by comparing the weight of rolls dry and soaked with saliva.

Decrease of the number of paper handkerchiefs used [ Time Frame: 1 month after the injection ] [ Designated as safety issue: No ]

Demonstrate, one month after the injection of botulinum toxin type A, a decrease of the number of paper handkerchiefs used. We ask the patient to count the number of handkerchiefs used a day.

Modification of the speech evaluation [ Time Frame: 1 month after the injection ] [ Designated as safety issue: No ]

Demonstrate, one month after the injection of botulinum toxin typeA, a modification of the speech evaluation (evaluation realized by speech evaluator)

Improvement of the quality of life [ Time Frame: 1 month after the injection ] [ Designated as safety issue: No ]

Demonstrate, one month after the injection of botulinum toxin type A, an improvement of the quality of life. Scale to estimate quality of life (ALSAQ-40), usually used with the patients affected by ALS

Description of patient cohort after the first injection [ Time Frame: 6 months after the injection ] [ Designated as safety issue: No ]

Describe cohort after the first injection: evolution of scores for every patient among Day0 and Month1, delay of appearance of the efficiency, the duration of effect of the treatment, the side effects, the modification of the consistency of the saliva and the possible necessity for re-injecting the patient at 3 months of follow-up.

The patient will benefit from an ultrasound guided injection of botulinum toxin A (Botox®) or placebo (NaCl 0.9 %) and will be followed up in consultation at 4, 12, 16 (if reinjection) and 24 weeks. He will be contacted by telephone in 2 and in 8 weeks (percentage of decrease of functional embarrassment, percentage of decrease of salivary secretion rate). He can be able to benefit in the open label phase of a botulinum toxin type A injection at the 12-week follow up if he estimates that first injection was not effective or if the efficiency of the first injection began to become blurred. After the 6 months of the study, the patient will benefit again from the usual follow-up as advised by the French consensus conference in November, 2005.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age > 18 years

Obtaining of a written consent after information

Diagnosis of probable or certain ALS according to the El Escorial criteria of the World Federation and Neurology Committee on Neuromuscular Diseases

Patient having a follow-up in an ALS center

Sialorrhea with VAS functional embarrassment > or equal at 50/100.

Patient beneficiary of Social Security regime

Exclusion Criteria:

Evolving disease associated with predictable survival < 1 month

Patient having previously received an injection of botulinum toxin in the salivary glands

Patient taking the other medical treatments for sialorrhea in the 7 days before the inclusion in the study (scopoderm, trihexyph'nidyle, atropine, ipatropium, amitriptyline, clomipramine, oxybutinine, diphenhydramine, beta-blockers)

Patient having benefited from radiotherapy or from surgery on the salivary glands

Behavioral problems, dementia or other psychiatric problems

Myasthenia

Known Pregnancy or absence of contraception recognized as effective, breast feeding

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01551940